Elections Complicate Overton's Confirmation, Set Stage for Increased Oversight

Democrats flipping both chambers of Congress in the 11/3 midterm elections has complicated the confirmation prospects of President Trump's nominee to lead FDA, Heidi Overton, while setting the stage for increased congressional scrutiny of the agency's drug approval decisions, vaccine policies and regulatory independence.

The election results leave Republicans with a narrow window to confirm Overton before Democrats take control of the Senate in January. The current Republican-controlled Senate is scheduled to return 11/9 for a lame-duck session, during which lawmakers also face a 12/11 government funding deadline.

Overton, a White House domestic policy adviser nominated in August, appeared before the Senate Health, Education, Labor and Pensions (HELP) Committee 9/24 but has not received a committee vote. Her nomination faced uncertainty even before the elections, with several Republican senators expressing concerns about vaccine policy and access to the abortion drug mifepristone (see earlier story).

HELP Committee chair Bill Cassidy (R-LA) questioned Overton about President Trump's statements concerning the measles, mumps and rubella vaccine. Other senators pressed her on whether political considerations would influence FDA decisions.

Overton defended the MMR vaccine as safe and effective and told senators that mifepristone remains safe and effective under its current FDA-approved labeling and risk evaluation and mitigation strategy. She also acknowledged an ongoing agency review of the drug's safety requirements.

The nomination had not advanced before the Senate recessed last month. With Democrats now positioned to control the chamber in January, failure to secure confirmation during the lame-duck session could leave the White House facing a substantially more difficult path to installing Overton as commissioner.

FDA has operated under acting leadership (Kyle Diamantas) since commissioner Martin Makary resigned in May.

The election results also could substantially change congressional oversight of FDA. Democratic control of the House and Senate gives the party authority to set committee agendas, conduct investigations, hold hearings, and seek agency records concerning FDA's scientific decision-making and implementation of administration policies.

Potential areas of scrutiny include changes to childhood vaccine recommendations, FDA's review of mifepristone, staffing reductions, expedited drug approval initiatives and allegations of political interference in regulatory decisions. The administration would retain executive control of FDA, however, and it's too early to tell how responsive the agency will be to Congressional information requests.

The immediate question is whether Senate Republicans will attempt to advance Overton's nomination before the new Congress convenes. If they do not, Trump could face a prolonged vacancy in FDA's top leadership position and a Democratic Senate with greater leverage over future nominees.